Designing, upgrading, and choosing the right instruments for a clinical lab are complicated tasks. Even for experienced laboratory directors and managers, it isn’t always apparent how such processes should be conducted, or…

According to FDA, today’s laboratory-developed tests are frequently manufactured using components and instruments that are not legally marketed for clinical use, and often rely on high-technology instrumentation and software to generate results…

Shifting interpretations of the CLIA guidelines will allow clinical laboratories to develop alternative quality control policies, replacing equivalent quality control procedures, as of January 1, 2016. Rose Mary Casados, president of COLA…

In written comments to FDA, the Association for Molecular Pathology argues that the agency should refrain from regulating the design, validation, and interpretation of next-generation sequencing procedures.

Designing, upgrading, and choosing the right instruments for a clinical lab are complicated tasks. Even for experienced laboratory directors and managers, it isn’t always apparent how such processes should be conducted, or how a lab should go about ensuring that its specific needs are addressed.

For an increasing number of laboratory directors and managers, coping with shifts in the healthcare marketplace is an everyday reality. But those who are prepared may see the challenges of such change as opportunities as well.

CLP spoke with Roger D. Klein, MD, JD, FCAP, medical director for molecular oncology at the Cleveland Clinic, and chair of the Association for Molecular Pathology ’s professional relations committee, to find out more about AMP’s revised policy on direct-to-consumer genetic testing,

After three recent outbreaks of carbapenem-resistant Enterobacteriaceae cast a light on the dangers associated with multi-drug-resistant infections, Nanosphere recently reaffirmed the clinical benefits of its Verigene gram-negative blood culture test.

Data from the ongoing NBRST trial suggest that Agendia’s BluePrint 80-gene molecular subtyping assay more accurately identifies molecular subgroups and may be a better guide for neoadjuvant chemotherapy than IHC/FISH assays.